A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin
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ClinicalTrials.gov Identifier: NCT00530946 |
Recruitment Status
:
Completed
First Posted
: September 18, 2007
Results First Posted
: April 13, 2009
Last Update Posted
: May 12, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension Hypercholesterolemia | Drug: Amlodipine 2.5mg/Atorvastatin 5mg Drug: Amlodipine 2.5mg/Atorvastatin 10mg Drug: Amlodipine 5mg/Atorvastatin 5mg Drug: Amlodipine 5mg/Atorvastatin 10mg | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 165 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multi-Center, Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin In The Treatment Of Concurrent Hypertension And Hyper-LDL-Cholesterolemia |
Study Start Date : | September 2007 |
Actual Primary Completion Date : | April 2008 |
Actual Study Completion Date : | April 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: CI-1038 2.5mg/5mg |
Drug: Amlodipine 2.5mg/Atorvastatin 5mg
Single pill combination, dosed once daily for 8 weeks
|
Active Comparator: CI-1038 2.5mg/10mg |
Drug: Amlodipine 2.5mg/Atorvastatin 10mg
Single pill combination, dosed once daily for 8 weeks
|
Active Comparator: CI-1038 5mg/5mg |
Drug: Amlodipine 5mg/Atorvastatin 5mg
Single pill combination, dosed once daily for 8 weeks
|
Active Comparator: CI-1038 5mg/10mg |
Drug: Amlodipine 5mg/Atorvastatin 10mg
Single pill combination, dosed once daily for 8 weeks
|
- Change in Systolic Blood Pressure [ Time Frame: 8 weeks ]
- Percent Change in Low Density Lipoprotein-Cholesterol [ Time Frame: 8 weeks ]
- Change in Systolic Blood Pressure From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks, and 8 weeks ]
- Change in Diastolic Blood Pressure From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ]
- Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ]
- Percent Change in Total Cholesterol From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ]
- Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ]
- Percent Change in Triglycerides From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ]
- Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks, and 8 weeks ]
- Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ]
- Change in Apolipoprotein B From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks, and 8 weeks ]

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Ages Eligible for Study: | 20 Years to 79 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The out-patient with concurrent hypertension and hyper-LDL-cholesterolemia is a male or female >=20 to <80 years of age at Visit 1.
- The SBP at Visit 4 (Week -1) and Visit 5 (Week 0) is continuously SBP >=140 mmHg and <180 mmHg,
- LDL-C >=140 mg/dL and <250 mg/dL at Visit 3 (Week -2) and 4 (Week -1).
Exclusion Criteria:
- Subjects who had experienced the following coronary artery disease within the past 3 months.
- Myocardial infarction
- Receiving PCI(percutaneous coronary intervention)or CABG (coronary artery bypass grafting)
- Any clinically meaningful valvular disease
- Subjects with a history of cerebrovascular diseases such as stroke or transient ischemic attack within the past 3 months.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530946
Japan | |
Pfizer Investigational Site | |
Fukuoka-shi, Fukuoka-ken, Japan | |
Pfizer Investigational Site | |
Kitakyushu-shi, Fukuoka-ken, Japan | |
Pfizer Investigational Site | |
Kurume-shi, Fukuoka-ken, Japan | |
Pfizer Investigational Site | |
Maebaru-shi, Fukuoka-ken, Japan | |
Pfizer Investigational Site | |
Annaka, Gunma, Japan | |
Pfizer Investigational Site | |
Sapporo-shi, Hokkaido, Japan | |
Pfizer Investigational Site | |
Teine, Hokkaido, Japan | |
Pfizer Investigational Site | |
Yokohama-shi, Kanagawa-ken, Japan | |
Pfizer Investigational Site | |
Yamashita-cho, Naka-ku, Kanagawa-ken, Japan | |
Pfizer Investigational Site | |
Kita-ku, Osaka-fu, Japan | |
Pfizer Investigational Site | |
Koshigaya-shi, Saitama-ken, Japan | |
Pfizer Investigational Site | |
Chofu, Tokyo, Japan | |
Pfizer Investigational Site | |
Kiyose, Tokyo, Japan | |
Pfizer Investigational Site | |
Setagaya-ku, Tokyo, Japan | |
Pfizer Investigational Site | |
Shinagawa-Ku, Tokyo, Japan | |
Pfizer Investigational Site | |
Shinagawa, Tokyo, Japan | |
Pfizer Investigational Site | |
Osaka, Japan |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
ClinicalTrials.gov Identifier: | NCT00530946 History of Changes |
Other Study ID Numbers: |
A3841058 |
First Posted: | September 18, 2007 Key Record Dates |
Results First Posted: | April 13, 2009 |
Last Update Posted: | May 12, 2009 |
Last Verified: | March 2009 |
Additional relevant MeSH terms:
Hypertension Hypercholesterolemia Vascular Diseases Cardiovascular Diseases Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Atorvastatin Calcium Amlodipine, atorvastatin drug combination Amlodipine |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors Antihypertensive Agents Calcium Channel Blockers Membrane Transport Modulators Vasodilator Agents |